- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01101126
Disease Management in Asthma or Chronic Obstructive Pulmonary Disease (COPD) Patients (ACDM-Maccabi)
Disease Management Program for Chronic Obstructive Pulmonary Diseases in Maccabi Health Services
연구 개요
상세 설명
The aim of the present study is to test the efficacy of a comprehensive community disease management program in patients with unstable chronic obstructive pulmonary disease (COPD) or asthma. The intervention is delivered by designated nurses and pulmonologists, in collaboration with the primary practitioners and other healthcare professionals at the community, in the Jerusalem and the Lowland District of Maccabi Health Services in Israel.
The main purpose is to evaluate the effect of the intervention on the use acute care and emergency health services for acute exacerbation of the lung disease.
Secondary objectives include the evaluation of the effect of the intervention on quality of life, physical function, pulmonary function test, depression and all-cause mortality.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Bat-Yam, 이스라엘
- Maccabi Pulmonary Clinic
-
Holon, 이스라엘
- Maccabi Pulmonary Clinic
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Men and women
- 40 years or older
- Having unstable COPD or Asthma
Exclusion Criteria:
- Significant LV dysfunction
- Other severe chronic morbidity compromising short-term survival
- Significant cognitive impairment or psychiatric disease
- Bedridden
- Homeless or no telephone connection
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Disease Management
Comprehensive care delivered by designated nurses and pulmonologists, in collaboration with the primary practitioners and other healthcare professionals in the community
|
Comprehensive pulmonary care including patient education of self-care, coordination of care, monitoring of patient adherence, providing advice in acute exacerbations
|
|
활성 비교기: Unual care
Care delivered by the primary practitioner with the advice of a consultant pulmonologist
|
Pulmonary disease is managed by the primary practitioner and a consultant pulmonologist
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Healthcare services utilization for acute exacerbations of pulmonary disease
기간: Every 6 months during 1-3 years' follow-up
|
The proportion of patients who, due to exacerbation of their COPD or asthma, have at least one out of hours visit to a "off-hour non-hospital based acute-care facilities", or a visit to a hospital emergency room, or a hospitalization within the two years of follow-up.
|
Every 6 months during 1-3 years' follow-up
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Quality of life
기간: Every 6 months during 1-3 years' follow-up
|
Health-related quality of life
|
Every 6 months during 1-3 years' follow-up
|
|
Pulmonary function tests
기간: Every 6 months during 1-3 years' follow-up
|
Pulmonary function tests
|
Every 6 months during 1-3 years' follow-up
|
|
Physical function
기간: Every 6 months during 1-3 years' follow-up
|
6-minutes walk test assessment
|
Every 6 months during 1-3 years' follow-up
|
|
Depression
기간: Every 6 months during 1-3 years' follow-up
|
PHQ-9 Questionnaire
|
Every 6 months during 1-3 years' follow-up
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Meir Raz, M.D., Maccabi Healthcare Services, Israel
- 연구 책임자: Ofra Kalter - Leibovici, M.D., Sheba Medical Center
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .